The Michael J. Fox Foundation has announced FDA approval of Inbrija, the first regulatory approval of a Parkinson's disease therapy directly funded by the foundation.
An inhaled levodopa powder, Inbriga is administered to Parkinson's patients experiencing an "off" episode, in which their PD symptoms are not well controlled by oral medication. MJFF provided a total of $1.3 million to partially fund phase I and phase II trials of the drug led by Civitas Therapeutics. In 2014, Civitas was acquired by Acorda Therapeutics, which continued development of the drug.
By reducing the risk for larger partners, MJFF has helped advance dozens of Parkinson's therapies, enabling its partners to build evidence of a therapy's safety and efficacy, which in turn can attract larger partners with resources for later-stage testing, the regulatory approval process, and commercialization. Additional treatments with the potential to slow or stop the progression of PD are moving through clinical trials with new partners after receiving funding from MJFF, while the FDA is reviewing another MJFF-funded Parkinson's treatment for "off" episodes.
"Our strategy of funding high-risk, high-reward projects with a focus on patient impact has paid off," said MJFF chief executive Todd Sherer. "Today, people with Parkinson's have a new option to manage life with the disease. Because of our foundation's investments, many more treatments to manage symptoms and to stop progression are moving closer to pharmacy shelves and patient hands."